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ISO 9001:2000 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Outline contents are as follows:Page iv: Foreword
Pages v to vii: Section 0 Introduction
Pages 1 to 14: Requirements
Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)'
Pages 2 to 14
Section 4: General Requirements
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Product Realization
Section 8: Measurement, analysis and improvement In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
Page 23: Bibliography The standard specifies six compulsory documents:Control of Documents (4.2.3)
Control of Records (4.2.4)
Internal Audits (8.2.2)
Control of Nonconforming Product / Service (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3) In addition to these, ISO 9001:2000 requires a Quality Policy and Quality Manual (which may or may not include the above documents).
The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.
Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source.
You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.
To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions.
You need to map out all key processes in your company; control them by monitoring, measurement and analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.
For each product your company makes, you need to establish quality objectives; plan processes; and document and measure results to use as a tool for improvement. For each process, determine what kind of procedural documentation is required. (Note: a “product” is hardware, software, services, processed materials, or a combination of these.)
You need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated.
You need to have clear requirements for purchased product.
You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.
You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness. (Note: you need a documented procedure for internal audits.)
You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.
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